Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.

NCT06179771 | Recruiting

• 2 other identifiers: 160716340810
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who are very ill either due to a severe infection, major organ injury, trauma or a major operation may require significant support with devices such as a dialysis machine for the kidneys or Extracorporeal Membrane Oxygenation (ECMO) for the heart and lungs. This is often due to a reaction of the body to the insult which is termed inflammation. The investigators would like to assess if the use of a device that can remove the agents driving this reaction can lead to a quicker recovery form the illness. The device is a blood filter called HA380 and it would be connected to either the dialysis machine or the ECMO circuit. The investigators want to assess the feasibility of conducting a study with the HA380 column. We will also evaluate if the use of the HA380 column has an effect on the time spent on dialysis or ECMO, time spent on the breathing machine, time spent requiring drugs to support blood pressure and time spent in the intensive care unit.

Conditions

Acute Kidney Injury; ARDS; Inflammation; Extracorporeal Circulation; Complications

Outcome Measures

Primary Outcomes (2)

• Successful use of HA380 column in critically ill patients.

  Number of patients unable to tolerate treatment with HA380 column.

  through study completion, an average of 24 months

• Ability to recruit the sample size of eligible patients within the study period.

  Proportion of the sample size recruited into the study during the study period.

  through study completion, an average of 24 months

Secondary Outcomes (4)

• Time spent on vasopressor therapy.

  From date admission to ICU, assessed up to 4 weeks

• Time spent in ICU

  From date of admission to ICU until the date of ICU discharge or date of death, which ever comes first, assessed up to 24 months

• ICU Mortality

  From the date of admission to ICU until the date of death from any cause during ICU stay, assessed up to 24 months

• Time spent on extracorporeal support

  From the date of admission to ICU, assessed up to 24 weeks

Study Arms (2)

Interventional

ACTIVE COMPARATOR

Patients assigned to interventional arm will receive treatment with a cytokine adsorption device (HA 380) within 72 hours of being admitted to ICU. This is in addition to standard evidence based ICU care. Each patient will receive 2 treatments each lasting a maximum of 6 hours in a 24 hour period.

Device: HA 380

Standard care

NO INTERVENTION

Patients assigned to the standard care arm would receive evidence based standard ICU care.

Interventions

HA 380 DEVICE

HA380 hemoperfusion cartridge is filled with neutral macroporous resin, mainly adsorbing molecules from 10 to 60 kDa. Because of the accurate 3D macroporous structure and over 54000 m2 adsorption surface area of the resin. The cartridge is attached to the extracorporeal circuit in series with the oxygenator/ filter of the extracorporeal circuit.

Interventional

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent obtained
• Male or Female, aged 18 years - 65 years.
• Admitted with a diagnosis of sepsis (according to sepsis-3 definition), trauma, ARDS of infectious or non-infectious aetiology, trauma or after major surgery
• Need for extracorporeal support and specifically renal replacement therapy (RRT) and/or ECMO.
• Vasopressor or inotropic therapy requirement at the time of RRT or ECMO support
• Within 72 hours of requiring extracorporeal support
• At least one of:
• CRP \> 100 mg/L (in the absence of immunosuppressive therapy/immunomodulation)
• Lactate \>2 mmol/L

You may not qualify if:

• The participant may not enter the trial if ANY of the following apply:
• Unable to obtain consent.
• Expected to die in the next 24 hours.
• Pre-existing chronic kidney disease - requiring dialysis /eGFR \< 30ml/min/1.73m2
• Pre-existing severe respiratory failure - e.g., requiring home oxygen/ home nebulisers/ poor exercise tolerance
• Chronic heart failure - NYHA class III and above
• Pregnancy
• Requirement for immediate immune modulation e.g., plasma exchange, high dose steroids , IV immunoglobulins (does not include vasoplegic dose of steroids or immune modulation for COVID 19)
• Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

Related Publications (6)

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• Fisher CJ Jr, Dhainaut JF, Opal SM, Pribble JP, Balk RA, Slotman GJ, Iberti TJ, Rackow EC, Shapiro MJ, Greenman RL, et al. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. Results from a randomized, double-blind, placebo-controlled trial. Phase III rhIL-1ra Sepsis Syndrome Study Group. JAMA. 1994 Jun 15;271(23):1836-43.

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• Opal SM, Fisher CJ Jr, Dhainaut JF, Vincent JL, Brase R, Lowry SF, Sadoff JC, Slotman GJ, Levy H, Balk RA, Shelly MP, Pribble JP, LaBrecque JF, Lookabaugh J, Donovan H, Dubin H, Baughman R, Norman J, DeMaria E, Matzel K, Abraham E, Seneff M. Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. The Interleukin-1 Receptor Antagonist Sepsis Investigator Group. Crit Care Med. 1997 Jul;25(7):1115-24. doi: 10.1097/00003246-199707000-00010.

  PMID: 9233735 RESULT

• REMAP-CAP Investigators; Gordon AC, Mouncey PR, Al-Beidh F, Rowan KM, Nichol AD, Arabi YM, Annane D, Beane A, van Bentum-Puijk W, Berry LR, Bhimani Z, Bonten MJM, Bradbury CA, Brunkhorst FM, Buzgau A, Cheng AC, Detry MA, Duffy EJ, Estcourt LJ, Fitzgerald M, Goossens H, Haniffa R, Higgins AM, Hills TE, Horvat CM, Lamontagne F, Lawler PR, Leavis HL, Linstrum KM, Litton E, Lorenzi E, Marshall JC, Mayr FB, McAuley DF, McGlothlin A, McGuinness SP, McVerry BJ, Montgomery SK, Morpeth SC, Murthy S, Orr K, Parke RL, Parker JC, Patanwala AE, Pettila V, Rademaker E, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Sligl WI, Turgeon AF, Turner AM, van de Veerdonk FL, Zarychanski R, Green C, Lewis RJ, Angus DC, McArthur CJ, Berry S, Webb SA, Derde LPG. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Apr 22;384(16):1491-1502. doi: 10.1056/NEJMoa2100433. Epub 2021 Feb 25.

  PMID: 33631065 RESULT

• Huang Z, Wang SR, Su W, Liu JY. Removal of humoral mediators and the effect on the survival of septic patients by hemoperfusion with neutral microporous resin column. Ther Apher Dial. 2010 Dec;14(6):596-602. doi: 10.1111/j.1744-9987.2010.00825.x.

  PMID: 21118369 RESULT

• Huang Z, Wang SR, Yang ZL, Liu JY. Effect on extrapulmonary sepsis-induced acute lung injury by hemoperfusion with neutral microporous resin column. Ther Apher Dial. 2013 Aug;17(4):454-61. doi: 10.1111/j.1744-9987.2012.01083.x. Epub 2012 Jun 21.

  PMID: 23931889 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hakeem Yusuff, MBBS

CONTACT

01162583816; hakeem.yusuff1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Consecutive study participants would be assigned using block randomisation into the intervention arm or the standard of care arm. Patients in the intervention arm would be treated with the HA380 column. The outcomes would be compared with patients who received standard ICU care .

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: December 22, 2023
• Study Start: September 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)